9.1.3 Biostatistics Core. Statistics provides a foundation for the design, conduct and analysis of experiments and studies based on data subject to random variation. Consequently, biostatistical support is critical to many investigators at the Winship Cancer Institute and biostatisticians play a fundamental role in both pre- and post-funding award stages of most cancer research studies. The Biostatistics Shared Core Resource in the WCI is a shared institutional resource for biostatistical consulting and related methodological research. It is recognized as a critical component of the research infrastructure at WCI. The Shared Resource serves as a focal point from which Center investigators may draw statistical expertise for planning, management, and analysis of their studies. The Biostatistics Shared Core includes the following services: 1) Provides statistical expertise in the design of experiments and studies, including research proposal development, sample size determination, randomization procedures, and plans for interim reviews and final analysis; 2) Assists with the writing of statistical components of manuscripts; 3) Reviews, in conjunction with the Clinical Translational Research Committee (CTRC), the integrity and statistical soundness of all studies involving human subjects; 4) Interacts and collaborates with the Clinical Trials Office in the development of protocols, and the monitoring and reporting of clinical data; 5) Conducts biostatistical methodology research on practical problems arising in cancer studies, such as mathematical modeling, applicable to cancer research. Types of research supported include clinical trials, translational research, epidemiology, behavioral, and basic science. The Biostatistics Shared Resource spans all Programs.